1st international workshop on colon capsule endoscopy
1st international workshop on colon capsule endoscopy
1st international workshop on colon capsule endoscopy
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1ST<br />
INTERNATIONAL<br />
WORKSHOP ON<br />
COLON CAPSULE<br />
ENDOSCOPY<br />
Workshop Report Vol. 1<br />
Detecting Col<strong>on</strong>ic Polyps and Cancer<br />
Page 2: Results and analysis of the European multicenter<br />
study of col<strong>on</strong> <strong>capsule</strong> <strong>endoscopy</strong> (CCE) with<br />
PillCam COLON<br />
Col<strong>on</strong> Capsule Endoscopy Regimen<br />
Page 3: Baseline prep and procedure; overview of<br />
<strong>on</strong>going research<br />
IBD and Mucosal Healing<br />
Page 4, 5: Assessment of col<strong>on</strong>ic inflammatory lesi<strong>on</strong>s;<br />
interim analysis of multicenter study <strong>on</strong> ulcerative<br />
colitis (UC); CCE and incomplete col<strong>on</strong>oscopy<br />
Ec<strong>on</strong>omics of CRC Screening<br />
Page 6: Ec<strong>on</strong>omic modeling data <strong>on</strong> cost-effectiveness<br />
of PillCam COLON for colorectal cancer (CRC)<br />
screening compared to col<strong>on</strong>oscopy<br />
CRC Screening and Other Indicati<strong>on</strong>s<br />
Page 7: Clinical cases using col<strong>on</strong> <strong>capsule</strong> <strong>endoscopy</strong><br />
for CRC screening and other indicati<strong>on</strong>s<br />
complementing col<strong>on</strong>oscopy<br />
Workflow and Practical Guidelines<br />
Page 8: Highlights of how CCE can fit into the workflow<br />
of a GI practice<br />
Visit www.ICCE.info<br />
for c<strong>on</strong>sensus material and archives of<br />
abstracts and ICCE Reports.<br />
To receive updates <strong>on</strong> ICCE events,<br />
click the C<strong>on</strong>tact Us link.<br />
*PillCam COLON has received a CE Mark, but is not cleared for<br />
marketing or available for commercial distributi<strong>on</strong> in the USA.<br />
Now in its seventh year, the Internati<strong>on</strong>al<br />
C<strong>on</strong>ference <strong>on</strong> Capsule Endoscopy<br />
(ICCE) remains the preeminent<br />
symposium for <strong>capsule</strong> <strong>endoscopy</strong><br />
(CE). As a result of physician interest,<br />
a dedicated, interactive <str<strong>on</strong>g>internati<strong>on</strong>al</str<strong>on</strong>g><br />
<str<strong>on</strong>g>workshop</str<strong>on</strong>g> was held for the first time to<br />
focus <strong>on</strong> the emerging modality of col<strong>on</strong><br />
<strong>capsule</strong> <strong>endoscopy</strong>. This publicati<strong>on</strong>, the<br />
ICCE Workshop Report Vol. 1, is a summary<br />
of selected presentati<strong>on</strong>s and scientific talks from the <str<strong>on</strong>g>workshop</str<strong>on</strong>g>.<br />
The <str<strong>on</strong>g>1st</str<strong>on</strong>g> ICCE Workshop <strong>on</strong> Col<strong>on</strong> Capsule Endoscopy c<strong>on</strong>vened in Berlin,<br />
Germany and was co-chaired by G. Costamagna (Italy) and W. Schmiegel<br />
(Germany). With joint sp<strong>on</strong>sorship by Given Imaging and Fujin<strong>on</strong>, the<br />
ICCE is still the <strong>on</strong>ly <str<strong>on</strong>g>internati<strong>on</strong>al</str<strong>on</strong>g> c<strong>on</strong>gress focusing entirely <strong>on</strong> <strong>capsule</strong><br />
<strong>endoscopy</strong>. Over 200 physicians and medical professi<strong>on</strong>als from 32<br />
countries came to this year’s dedicated <str<strong>on</strong>g>workshop</str<strong>on</strong>g> to learn more about<br />
col<strong>on</strong> <strong>capsule</strong> <strong>endoscopy</strong> (CCE) and PillCam® COLON.<br />
Presentati<strong>on</strong>s included recent scientific data <strong>on</strong> using PillCam COLON to<br />
evaluate col<strong>on</strong>ic mucosa. Topics included colorectal cancer, col<strong>on</strong> polyps,<br />
col<strong>on</strong>ic inflammatory lesi<strong>on</strong>s and ulcerative colitis, scoring indexes for<br />
characterizing col<strong>on</strong>ic mucosal damage and healing, and regimens (prep<br />
and procedures) for CCE. There were lively discussi<strong>on</strong>s <strong>on</strong> ec<strong>on</strong>omics and<br />
optimizing the utility of CCE in current clinical practice and potential<br />
screening applicati<strong>on</strong>s. Several sessi<strong>on</strong>s also emphasized the <strong>on</strong>going<br />
impact of the updated ICCE C<strong>on</strong>sensus, published in Endoscopy, and CE<br />
for the esophagus and small bowel.<br />
Also at the Berlin meeting, ICCE Learning Center activities included<br />
hands-<strong>on</strong> dem<strong>on</strong>strati<strong>on</strong>s of the Given Imaging PillCam Platform’s new<br />
RAPID® software features for image-enhancement and RAPID Access<br />
for CE in a networked envir<strong>on</strong>ment; as well as the latest techniques for<br />
double-ballo<strong>on</strong> <strong>endoscopy</strong> (DBE) from Fujin<strong>on</strong>. This year’s European<br />
Capsule Endoscopy Group (ECEG) Research Grants were awarded at the<br />
Berlin meeting (see page 8).<br />
For more informati<strong>on</strong> <strong>on</strong> the ICCE, visit the website www.ICCE.info for<br />
summaries (including issues of the ICCE C<strong>on</strong>ference Report), c<strong>on</strong>sensus<br />
material, and an abstract archive. The website is also accessible from the<br />
www.CapsuleEndoscopy.org homepage.
2 ICCE Workshop Report Vol. 1<br />
Detecting Col<strong>on</strong>ic Polyps and Cancer<br />
The European multicenter study data presented by J. Devière<br />
(Belgium) at the <str<strong>on</strong>g>1st</str<strong>on</strong>g> Internati<strong>on</strong>al Workshop <strong>on</strong> Col<strong>on</strong><br />
Capsule Endoscopy represents the largest clinical study to<br />
date <strong>on</strong> CCE. Principal investigator of the PillCam COLON<br />
feasibility and pilot studies R. Eliakim (Israel) introduced<br />
Devière’s lecture and the scientific sessi<strong>on</strong>s with a quote from<br />
the American Gastrological Associati<strong>on</strong> (AGA) Future Trends<br />
Report, Gastroenterology (2006; 131:1287-1312):<br />
“Wireless <strong>capsule</strong> <strong>endoscopy</strong> represents <strong>on</strong>e of the most<br />
significant and exciting breakthroughs in endoscopic<br />
technology in recent years. The <strong>capsule</strong> has clearly<br />
revoluti<strong>on</strong>ized small bowel imaging… A versi<strong>on</strong> for<br />
imaging the col<strong>on</strong> is under study and, if proven effective,<br />
will clearly represent a sec<strong>on</strong>d revoluti<strong>on</strong> in bowel imaging.”<br />
This potential for CCE as an effective tool was reinforced by<br />
C. Hassan (Italy) in his presentati<strong>on</strong> of ec<strong>on</strong>omics modeling<br />
data (<strong>on</strong> page 6).<br />
PillCam COLON Capsule Endoscopy<br />
Compared to Col<strong>on</strong>oscopy in Detecti<strong>on</strong> of<br />
Col<strong>on</strong> Polyps and Cancers: Analysis of a<br />
Prospective Multicenter European Study<br />
J. Devière, Hôpital Erasme, Brussels, Belgium<br />
Devière presented an analysis of a multicenter European study<br />
of detecting col<strong>on</strong> polyps and cancers using CCE with the<br />
PillCam COLON compared to col<strong>on</strong>oscopy. Final analysis<br />
covered prospective data from 320 patients from 8 sites in<br />
Belgium, France, Germany, Italy, Spain, and the UK. He<br />
noted that in pilot studies, CCE with PillCam COLON has<br />
been shown to be safe and able to visualize col<strong>on</strong> polyps and<br />
cancers. This study was c<strong>on</strong>ducted with the primary objective<br />
to assess the accuracy of PillCam COLON to col<strong>on</strong>oscopy.<br />
Patients included in this study were known to have (age ≥ 18<br />
years) or were suspected of having (age ≥ 50 years) col<strong>on</strong>ic<br />
disease and were referred for col<strong>on</strong>oscopy. Patients received<br />
a standard PEG-based col<strong>on</strong> prep and ingested the PillCam<br />
COLON video <strong>capsule</strong> in the morning. The PillCam COLON<br />
procedure / regimen also included a prokinetic medicati<strong>on</strong> and<br />
additi<strong>on</strong>al small doses of laxatives. No sedati<strong>on</strong>, tube inserti<strong>on</strong>,<br />
or air insufflati<strong>on</strong> was required. Independent physicians<br />
performed CCE interpretati<strong>on</strong> and col<strong>on</strong>oscopy (gold<br />
standard) after PillCam COLON video <strong>capsule</strong> excreti<strong>on</strong>.<br />
Review of PillCam COLON and col<strong>on</strong>oscopy studies was by<br />
double-blinded review process.<br />
Results: A total of 328 patients (mean age: 59 years; range:<br />
22-84) were enrolled; 320 were included in the final analysis.<br />
There was 1 severe adverse event related to col<strong>on</strong>oscopy.<br />
PillCam COLON video <strong>capsule</strong>s were excreted within 10<br />
hours post-ingesti<strong>on</strong> in 93% of the patients and within 6 hours<br />
in 69%. Quality of col<strong>on</strong> cleansing was evaluated according<br />
to a 4-point scale; 72% of the patients had col<strong>on</strong> cleansing<br />
levels of Good-to-Excellent. Accuracy parameters for polyp<br />
detecti<strong>on</strong> with PillCam COLON compared to col<strong>on</strong>oscopy<br />
were particularly encouraging for Good-to-Excellent col<strong>on</strong><br />
cleansing levels. See Tables 1-3.<br />
Table 1. Reas<strong>on</strong>s for Referral<br />
Patients known<br />
to have col<strong>on</strong>ic disease<br />
Patients suspected of<br />
having col<strong>on</strong>ic disease<br />
Age 18-49 y Age ≥ 50 y All<br />
patients<br />
57 58 115 (35%)<br />
7 206 213 (65%)<br />
All patients 64 (19.5%) 264 (80.5%) 328<br />
Table 2. PillCam COLON Findings and Accuracy (Compared to<br />
Col<strong>on</strong>oscopy)<br />
Findings No. of<br />
Patients<br />
Sensitivity Specificity Positive<br />
Predictive<br />
Value<br />
*PillCam COLON has received a CE Mark, but is not cleared for marketing or available for commercial distributi<strong>on</strong> in the USA.<br />
Negative<br />
Predictive<br />
Value<br />
In patients with Good-to-Excellent cleansing levels (72% of all<br />
patients)<br />
Any size<br />
polyps<br />
Significant<br />
finding*<br />
149 76% 80% 88% 63%<br />
93 75% 83% 75% 83%<br />
Polyp ≥ 6 59 75% 84% 62% 90%<br />
Polyp ≥ 10 33 76% 98% 89% 96%<br />
In all patients (n=320)<br />
Any size<br />
polyps<br />
Significant<br />
finding*<br />
212 72% 78% 86% 59%<br />
134 66% 82% 72% 77%<br />
Polyp ≥ 6 87 64% 84% 60% 86%<br />
Polyp ≥ 10 50 60% 98% 83% 93%<br />
* At least 1 polyp ≥ 6 mm or ≥ 3 polyps of any size.<br />
References<br />
Note: Throughout this document, the term col<strong>on</strong>oscopy refers to c<strong>on</strong>venti<strong>on</strong>al optical col<strong>on</strong>oscopy.<br />
C<strong>on</strong>clusi<strong>on</strong>s: CCE with PillCam COLON is a new minimallyinvasive<br />
and safe technology for visualizing the col<strong>on</strong>. PillCam<br />
COLON shows encouraging accuracy for detecting polyps<br />
compared to col<strong>on</strong>oscopy and may be an alternative for patients<br />
who cannot or are unwilling to undergo col<strong>on</strong>oscopy.<br />
1. Devière J, Schoofs N, Munoz Navas M, Fernandez-Urien I, Carretero<br />
C, Lapalus MG, P<strong>on</strong>ch<strong>on</strong> T, Gay G, Delvaux M, Neuhaus H, Philipper M,<br />
Costamagna G, Ricci<strong>on</strong>i ME, Spada C, Fraser C, Postgate A, Fitzpatrick<br />
A, Hagenmuller F, Keuchel M, Van Gossum A. PillCam COLON <strong>capsule</strong><br />
<strong>endoscopy</strong> compared to col<strong>on</strong>oscopy in detecti<strong>on</strong> of col<strong>on</strong> polyps and cancers.<br />
Gastroenterology 2008;134(4)(suppl 1):A-38.<br />
2. Eliakim R, Fireman Z, Gralnek IM, Yassin K, Waterman M, Kopelman Y,<br />
Lachter J, Koslowsky B, Adler SN. Evaluati<strong>on</strong> of the PillCam Col<strong>on</strong> <strong>capsule</strong> in<br />
the detecti<strong>on</strong> of col<strong>on</strong>ic pathology: results of the first multicenter, prospective,<br />
comparative study. Endoscopy 2006;38(10):963-970.<br />
3. Schoofs N, Devière J, Van Gossum A. PillCam Col<strong>on</strong> <strong>capsule</strong> <strong>endoscopy</strong><br />
compared with col<strong>on</strong>oscopy for colorectal tumor diagnosis: a prospective pilot<br />
study. Endoscopy 2006;38(10):971-977.<br />
4. Lewis B, Rex D, Lieberman D. Capsule col<strong>on</strong>oscopy- an interim report of<br />
a pilot 3 arm, blinded trial of <strong>capsule</strong> col<strong>on</strong>oscopy, virtual col<strong>on</strong>oscopy and<br />
col<strong>on</strong>oscopy. Am J of Gastroenterol 2006;101(suppl II):1470.
Col<strong>on</strong> Capsule Endoscopy Regimen<br />
The current baseline regimen for CE with PillCam COLON<br />
is shown in Table 3. Several sessi<strong>on</strong>s at ICCE Berlin covered<br />
<strong>on</strong>going research <strong>on</strong> new prep and procedure variati<strong>on</strong>s<br />
(including day vs night procedures) in studies presented by<br />
S. Bar-Meir (Israel), T. Brechmann (Germany), C. Carretero<br />
(Spain), G. Costamagna (Italy), Z. Fireman (Israel), and M.<br />
Table 3. Baseline Col<strong>on</strong> Prep and Procedure (Regimen Used in Multicenter European Study)<br />
Schedule Col<strong>on</strong> prep and procedure<br />
Day before Clear liquid diet all day (no breakfast) + 3 L Colopeg ®<br />
Exam day 6:00 – 7:00 1 L Colopeg<br />
7:45 – 8:00 20 mg Domperid<strong>on</strong>e + (after 15 min) PillCam COLON ingesti<strong>on</strong><br />
10:00 *Booster I: 45 mL NaP<br />
Only if needed 14:00 Booster II: 30 mL NaP<br />
16:30 10 mg Bisacodyl suppository<br />
*Pending exit of PillCam COLON from the stomach (verified via RAPID Real-Time device)<br />
Philipper (Germany). Presentati<strong>on</strong>s by M. Delvaux (France)<br />
and H. Schulz (Germany) <strong>on</strong> PillCam COLON experience in<br />
regi<strong>on</strong>al studies also included variati<strong>on</strong>s of the base regimen in<br />
office-based, clinic-based, and hospital settings which evaluated<br />
daily workflow for CE of the col<strong>on</strong>.<br />
93% of patients in the European multicenter study completed the PillCam COLON exam and excreted the <strong>capsule</strong><br />
within 10 hrs post-ingesti<strong>on</strong>; 69% completed the PillCam COLON exam without need for Booster II and within 6 hrs.<br />
Detecting Col<strong>on</strong>ic Polyps and Cancer<br />
Note the different views of col<strong>on</strong> mucosa: With insufflati<strong>on</strong> in col<strong>on</strong>oscopy, polyps can appear flattened; PillCam COLON<br />
images the mucosa through clear fluid without using insufflati<strong>on</strong>.<br />
Col<strong>on</strong>oscopy PillCam COLON<br />
Pedunculated polyp in transverse col<strong>on</strong><br />
Polyp in right col<strong>on</strong><br />
ICCE Workshop Report Vol. 1 3<br />
Col<strong>on</strong>oscopy PillCam COLON<br />
Small polyps in rectum<br />
Polypoid mass in right flexure<br />
*PillCam COLON has received a CE Mark, but is not cleared for marketing or available for commercial distributi<strong>on</strong> in the USA.
4 ICCE Workshop Report Vol. 1<br />
IBD and Mucosal Healing<br />
The potential role of CCE in evaluating col<strong>on</strong>ic inflammatory<br />
bowel disease and mucosal healing was an important topic<br />
at the <str<strong>on</strong>g>workshop</str<strong>on</strong>g>. The presentati<strong>on</strong> by J. J. Y. Sung (H<strong>on</strong>g<br />
K<strong>on</strong>g) of interim clinical results of the first pilot study<br />
using PillCam COLON for evaluating ulcerative colitis was<br />
received with enthusiasm. J. F. Colombel (Belgium) discussed<br />
the various needs for evaluating mucosal injury and healing<br />
in ileocol<strong>on</strong>ic Crohn’s disease. During questi<strong>on</strong>-and-answer<br />
sessi<strong>on</strong>s, panel members and the audience discussed applying<br />
existing tools such as the Lewis Score (integrated in RAPID<br />
5) for characterizing col<strong>on</strong>ic lesi<strong>on</strong>s, as well as other areas of<br />
future study.<br />
Evaluati<strong>on</strong> of PillCam COLON Capsule<br />
Endoscopy in the Assessment of Col<strong>on</strong>ic<br />
Inflammatory Lesi<strong>on</strong>s in Ulcerative Colitis: An<br />
Interim Analysis<br />
J. J. Y. Sung, Chinese University of H<strong>on</strong>g K<strong>on</strong>g, H<strong>on</strong>g<br />
K<strong>on</strong>g, China<br />
Introducing this interim analysis, Sung emphasized that active<br />
ulcerative colitis (UC) is associated with an increased risk of<br />
colorectal dysplasia and cancer. Treatment of UC should be<br />
closely m<strong>on</strong>itored and follow the level of severity of col<strong>on</strong>ic<br />
inflammati<strong>on</strong>. There is also a need for surveillance of CRC<br />
especially in patients with extensive disease for prol<strong>on</strong>ged<br />
periods. In previous studies, CCE with PillCam COLON has<br />
been shown safe and able to dem<strong>on</strong>strate col<strong>on</strong> polyps and<br />
cancer. The primary objective of this <strong>on</strong>going pilot study was<br />
to evaluate the accuracy of <strong>capsule</strong> <strong>endoscopy</strong> with the PillCam<br />
COLON in m<strong>on</strong>itoring col<strong>on</strong>ic inflammati<strong>on</strong> and UC in<br />
comparis<strong>on</strong> to col<strong>on</strong>oscopy.<br />
Inclusi<strong>on</strong> criteria were patients 18-70 years old referred to<br />
col<strong>on</strong>oscopy for suspected or known inflammatory lesi<strong>on</strong>s or<br />
other col<strong>on</strong>ic disease. Patients had a traditi<strong>on</strong>al PEG col<strong>on</strong><br />
prep and ingested the video <strong>capsule</strong> in the morning. The<br />
PillCam COLON procedure was designed to enhance <strong>capsule</strong><br />
propulsi<strong>on</strong> and maintain clean col<strong>on</strong> during the procedure. No<br />
sedati<strong>on</strong>, intubati<strong>on</strong>, or insufflati<strong>on</strong> was required. Following<br />
<strong>capsule</strong> excreti<strong>on</strong>, col<strong>on</strong>oscopy (gold standard) was performed<br />
the same day. Independent physicians performed PillCam<br />
COLON and col<strong>on</strong>oscopy evaluati<strong>on</strong>s. UC disease was activity<br />
classified into 1 of 3 groups (according to findings):<br />
1. Normal or not related to UC (polyps, vascular lesi<strong>on</strong>s,<br />
diverticulitis)<br />
2. N<strong>on</strong>-active UC (pseudopolyps, scarring, mosaic pattern,<br />
cobblest<strong>on</strong>ing)<br />
3. Active UC (ulcer, erythema, erosi<strong>on</strong>s, edema, exudates,<br />
proctitis)<br />
Results: 42 patients (mean age: 48 years; range: 27-68) were<br />
enrolled; 40 included in the interim analysis. No adverse events<br />
were related to the PillCam COLON video <strong>capsule</strong>. Capsules<br />
were excreted within 8:30 hours post-ingesti<strong>on</strong> in 97.5% of the<br />
patients and within 5:30 hours in 60%. Col<strong>on</strong>oscopy detected<br />
active UC in 22 patients, and the accuracy of PillCam COLON<br />
compared to col<strong>on</strong>oscopy was 77% sensitivity, 78% specificity,<br />
81% PPV, and 74% NPV. The agreement level (kappa) between<br />
PillCam COLON and col<strong>on</strong>oscopy<br />
of classifying the UC disease<br />
into 1 of the 3 groups was 0.6.<br />
See Tables 4 and 5.<br />
C<strong>on</strong>clusi<strong>on</strong>s: CCE with PillCam<br />
COLON is a safe and well-tolerated<br />
procedure. It has encouraging<br />
accuracy for detecti<strong>on</strong> of active<br />
UC and substantial agreement with<br />
col<strong>on</strong>oscopy. The high acceptability<br />
of PillCam COLON may increase<br />
adherence to m<strong>on</strong>itoring activities<br />
in UC patients.<br />
Areas of future research:<br />
• Development of a scoring system<br />
for the assessment of the severity<br />
of col<strong>on</strong>ic inflammati<strong>on</strong> in UC by<br />
using PillCam COLON in order<br />
to tailor individual treatment<br />
• Use of PillCam to define the<br />
extent of disease involvement in<br />
UC using PillCam COLON<br />
• Use of PillCam COLON in<br />
surveillance for cancer<br />
Table 4. Reas<strong>on</strong>s for Referral<br />
No. of<br />
Patients<br />
Abdominal<br />
Pain<br />
10 (25%) �<br />
Ulcerative<br />
Colitis<br />
23 (57%) �<br />
Rectal<br />
Bleeding<br />
4 (10%) �<br />
2 (5%) � �<br />
1 (3%) � � �<br />
Table 5. Classificati<strong>on</strong> of UC Activity (Per Patient Analysis)<br />
Col<strong>on</strong>oscopy<br />
PillCam<br />
COLON<br />
Normal / not<br />
related to UC<br />
N<strong>on</strong>-active<br />
UC<br />
Normal / not<br />
related to UC<br />
12<br />
(80%)<br />
0<br />
N<strong>on</strong>-active<br />
UC<br />
Active<br />
UC<br />
0 4<br />
2<br />
(67%)<br />
Active UC 3 1<br />
Classificati<strong>on</strong> of<br />
Col<strong>on</strong>oscopy (left colum<br />
Pseudopolyps; flattened<br />
insufflati<strong>on</strong> at<br />
1<br />
17<br />
(77%)<br />
Substantial agreement between PillCam COLON and col<strong>on</strong>oscopy<br />
(kappa statistic = 0.6).<br />
*PillCam COLON has received a CE Mark, but is not cleared for marketing or available for commercial distributi<strong>on</strong> in the USA.<br />
Diffuse
Ulcerative Colitis Disease Activity<br />
n) and PillCam COLON Views of UC<br />
erythema<br />
appearance at left due to<br />
col<strong>on</strong>oscopy<br />
J. J. Y. Sung, Chinese University of H<strong>on</strong>g K<strong>on</strong>g, H<strong>on</strong>g K<strong>on</strong>g, China<br />
Following is a case where col<strong>on</strong>oscopy was incomplete because<br />
of the presence of a sigmoid stricture while the PillCam<br />
COLON video <strong>capsule</strong> allowed a complete examinati<strong>on</strong> of the<br />
col<strong>on</strong>. CCE enabled detecti<strong>on</strong> of col<strong>on</strong>ic polyps proximal to<br />
the sigmoid stricture that would have otherwise been missed;<br />
it was reliable in localizing the site of the findings (c<strong>on</strong>firmed<br />
at repeat col<strong>on</strong>oscopy) both for polyps and col<strong>on</strong>ic Crohn’s<br />
Col<strong>on</strong>ic polyps missed at incomplete col<strong>on</strong>oscopy<br />
Large sessile polyp > 10 mm<br />
suggestive of<br />
adenomatous polyp<br />
Erosi<strong>on</strong>s<br />
Small sessile polyp < 6 mm<br />
suggestive of<br />
hyperplastic lesi<strong>on</strong><br />
ICCE Workshop Report Vol. 1 5<br />
Erosi<strong>on</strong>s, edema,<br />
erythema<br />
Severe erosi<strong>on</strong>s, edema,<br />
erythema<br />
Pseudopolyps Mosaic pattern<br />
disease; it also provided accurate estimati<strong>on</strong> of polyp size when<br />
compared to col<strong>on</strong>oscopy as a gold standard.<br />
Furthermore, PillCam COLON findings guided therapy<br />
(medical treatment of col<strong>on</strong>ic Crohn’s disease and polypectomy)<br />
and improved patient management and outcomes. The patient<br />
is in good clinical c<strong>on</strong>diti<strong>on</strong> after 18 m<strong>on</strong>ths of follow-up.<br />
PillCam COLON Complements Incomplete Col<strong>on</strong>oscopy<br />
Col<strong>on</strong>ic Crohn’s disease in same patient<br />
Erosi<strong>on</strong>s, narrowing, and<br />
ulcer in left col<strong>on</strong><br />
C. Spada, Catholic University and European Endoscopy Training Center, Rome, Italy<br />
*PillCam COLON has received a CE Mark, but is not cleared for marketing or available for commercial distributi<strong>on</strong> in the USA.<br />
Hyperemia, ulcerati<strong>on</strong>s<br />
in rectum<br />
Active UC N<strong>on</strong>-Active UC
6 ICCE Workshop Report Vol. 1<br />
Ec<strong>on</strong>omics of CRC Screening<br />
At the ICCE Workshop <strong>on</strong> Col<strong>on</strong> Capsule Endoscopy a<br />
number of presentati<strong>on</strong>s covered different aspects of CRC<br />
screening—especially the potential of CCE with PillCam<br />
COLON to improve patient compliance, and subsequently<br />
improve outcomes. W. Schmiegel (Germany) discussed<br />
indicati<strong>on</strong>s for screening and surveillance of high-risk groups<br />
such as patients with a family history of CRC and hereditary<br />
n<strong>on</strong>polyposis col<strong>on</strong> cancer (HNPCC), familial adenomatous<br />
polyposis (FAP), and Peutz-Jeghers syndrome (PJS).<br />
For the first time at ICCE, an ec<strong>on</strong>omic modeling study was<br />
presented <strong>on</strong> CCE in the average-risk, general populati<strong>on</strong><br />
that fails to comply with current CRC screening guidelines;<br />
C. Hassan (Italy) c<strong>on</strong>cluded that PillCam COLON may be<br />
a cost-effective approach to preventing CRC in this general<br />
patient populati<strong>on</strong>. This study was also published in the May<br />
issue of Endoscopy.<br />
Cost-effectiveness of Colorectal Cancer<br />
Screening with Capsule Endoscopy<br />
C. Hassan, Nuovo Regina Margherita Hospital, Rome,<br />
Italy<br />
Hassan pointed out that CRC screening rates remain<br />
disappointingly low when compared to the success of other<br />
cancer screening programs. Colorectal cancers are preventable<br />
through early detecti<strong>on</strong>, and this minimally-invasive opti<strong>on</strong><br />
may aid in significantly reducing the more than 212,000<br />
annual deaths in Europe due to colorectal cancer. The aim<br />
of this analysis was to provide a model to assess the cost<br />
and effectiveness of populati<strong>on</strong>-based screening for CRC<br />
using <strong>capsule</strong> <strong>endoscopy</strong> compared with that of a standard<br />
col<strong>on</strong>oscopy screening program.<br />
A Markov mathematical model was c<strong>on</strong>structed to simulate a<br />
comparis<strong>on</strong> of CRC screening scenarios comparing PillCam<br />
COLON with standard col<strong>on</strong>oscopy. Model parameters were<br />
varied to simulate alterati<strong>on</strong>s in cost, thresholds for treatments,<br />
sensitivities and specificities, and screening adherence rates.<br />
Through pooled analyses, it was determined that a threshold<br />
≥ 6 mm for polypectomy referral substantially reduced costs<br />
while <strong>on</strong>ly minimally impacting efficacy.<br />
[Editor’s Note: Markov models are useful when a decisi<strong>on</strong><br />
problem involves risk that is c<strong>on</strong>tinuous over time, when the<br />
timing of events is important, and when important events may<br />
happen more than <strong>on</strong>ce.]<br />
C<strong>on</strong>clusi<strong>on</strong>s: Cost-effectiveness of CRC screening using<br />
PillCam COLON will mainly depend <strong>on</strong> its ability to<br />
improve compliance in the general populati<strong>on</strong>. The very low<br />
adherence achieved by col<strong>on</strong>oscopy prompts an urgent need<br />
for minimally-invasive alternatives, such as <strong>capsule</strong> <strong>endoscopy</strong>.<br />
(See Figures 1 and 2.) The impact of compliance <strong>on</strong> the<br />
effectiveness of CE is substantial, that of efficacy marginal;<br />
a minimally-invasive CE strategy also implies a filter for<br />
post-CE [polypectomy] referrals. Based <strong>on</strong> uptake for CE in<br />
other areas of the GI tract (small bowel, esophagus), there is<br />
ubiquitous expectati<strong>on</strong> that CE will achieve better acceptance<br />
and thus will increase compliance to screening. If such uptake<br />
Figure 1. Crucial Role of Patient Compliance in the<br />
Effectiveness of CRC Screening<br />
Clinical<br />
Efficacy<br />
The impact of compliance <strong>on</strong> the effectiveness of CE is<br />
substantial, that of efficacy marginal. Thus, cost-effectiveness<br />
of CRC screening using PillCam COLON will mainly depend<br />
<strong>on</strong> its ability to improve compliance in the general populati<strong>on</strong>.<br />
The very low adherence achieved by col<strong>on</strong>oscopy prompts<br />
an urgent need for minimally-invasive alternatives, such as<br />
<strong>capsule</strong> <strong>endoscopy</strong>. PillCam COLON holds great promise<br />
in improving compliance to CRC screening standards in the<br />
general populati<strong>on</strong>.<br />
mirrors that for other cancer screenings, CE will be an efficient<br />
strategy for CRC preventi<strong>on</strong>, with cost-effectiveness potentially<br />
superior to col<strong>on</strong>oscopy. PillCam COLON holds great promise<br />
in improving compliance to CRC screening standards in the<br />
general populati<strong>on</strong>.<br />
References<br />
EFFECTIVENESS<br />
of CRC screening<br />
Patient<br />
Compliance<br />
EFFECTIVENESS = Efficacy x Compliance<br />
Figure 2. Cost-effectiveness CE vs Col<strong>on</strong>oscopy<br />
Col<strong>on</strong>oscopy compliance = 18%<br />
300,000<br />
250,000<br />
200,000<br />
150,000<br />
100,000<br />
0<br />
0% 10%<br />
Compliance (%)<br />
20% 30% 40% 50%<br />
Compliance (%)<br />
60% 70%<br />
1. Hassan C, Zullo A, Winn S, Morini S. Cost-effectiveness of <strong>capsule</strong><br />
<strong>endoscopy</strong> in screening for colorectal cancer. Endoscopy. 2008 Feb (E Pub).<br />
2. S<strong>on</strong>nenberg FA, Beck JR. Markov models in medical decisi<strong>on</strong> making:<br />
a practical guide. Med Decis Making. 1993 Oct-Dec;13(4):322-38. http://<br />
www.ncbi.nlm.nih.gov/pubmed/8246705.<br />
*PillCam COLON has received a CE Mark, but is not cleared for marketing or available for commercial distributi<strong>on</strong> in the USA.<br />
Cost/life-year saved ($)<br />
50,000<br />
Col<strong>on</strong>oscopy<br />
BETTER<br />
CE compliance<br />
threshold<br />
26%<br />
CE BETTER
CRC Screening and Other Indicati<strong>on</strong>s<br />
Several presentati<strong>on</strong>s focused <strong>on</strong> studies and patient cases using<br />
PillCam COLON for CRC screening as well as other indicati<strong>on</strong>s<br />
complementing col<strong>on</strong>oscopy, ie, patients unwilling or unable to<br />
have col<strong>on</strong>oscopy. S. Chaussade (France) presented interim data <strong>on</strong><br />
behalf of the French Ministry of Health research grant c<strong>on</strong>sortium<br />
(PHRC) study led by J. Galmiche (France). In his c<strong>on</strong>clusi<strong>on</strong>s,<br />
Chaussade emphasized the “excellent acceptability and tolerance<br />
of PillCam COLON in patients screened for col<strong>on</strong>ic neoplasia.”<br />
During presentati<strong>on</strong>s of the patient cases (this page), there<br />
were interactive questi<strong>on</strong>s to the audience that stimulated lively<br />
discussi<strong>on</strong>s <strong>on</strong> challenging aspects of the different cases and patient<br />
management strategies involving CCE and follow-up modalities.<br />
Note: Images not marked PillCam COLON are from col<strong>on</strong>oscopy.<br />
Adenomatous polyps<br />
CRC screening of patient with family history of adenomatous polyps; she<br />
presented with occasi<strong>on</strong>al upper gastric pain and reflux; no weight loss or<br />
anemia/bleeding. CCE findings: Multiple polyps were identified.<br />
Post-CCE: Col<strong>on</strong>oscopy and polypectomy of 6 polyps was performed:<br />
4 were adenomas. Patient is well and scheduled for follow-up col<strong>on</strong>oscopy<br />
in 2 years.<br />
M. Philipper, Evangelisches Krankenhaus, Duesseldorf, Germany<br />
Hyperplastic polyps<br />
Patient presented with upper- and mid-abdominal pain for 6 m<strong>on</strong>ths and<br />
had normal bowel habits, no visible blood in stool, and no weight loss. CCE<br />
findings: 4 polyps were detected. Post-CCE: col<strong>on</strong>oscopy and polypectomy<br />
were performed: 4 hyperplastic polyps (1 polyp was > 1 cm in transversum).<br />
M. Keuchel, Asklepios Klinik Alt<strong>on</strong>a, Hamburg, Germany<br />
ICCE Workshop Report Vol. 1 7<br />
Serrated adenoma in sigmoid col<strong>on</strong><br />
CRC screening of asymptomatic patient with hypertensi<strong>on</strong> and no pers<strong>on</strong>al<br />
or family history of col<strong>on</strong>ic polyps or cancer. Patient refused col<strong>on</strong>oscopy<br />
and requested a minimally-invasive, comfortable method of CRC screening.<br />
CCE findings: Pedunculated polyp in sigmoid col<strong>on</strong> was detected.<br />
Post-CCE: Based <strong>on</strong> CCE findings, patient agreed to col<strong>on</strong>oscopy (to<br />
c<strong>on</strong>firm CCE findings) and polypectomy. Histological diagnosis: serrated<br />
adenoma. Patient is well and scheduled for follow-up in 1 year.<br />
J. M. Herrerías, Hospital Universitario Virgen Macarena, Seville,<br />
Spain<br />
Hyperplastic polyp<br />
Patient presented for regular CRC screening (for adults ≥ 55 years<br />
old, according to regi<strong>on</strong>al guidelines) with no major complaints except<br />
infrequent diarrhea. CCE findings: 1 small polyp was detected. Post-CCE:<br />
col<strong>on</strong>oscopy was performed; polyp was removed during biopsy. Histologic<br />
diagnosis: hyperplastic polyp. Patient is well with no symptoms after 1 year.<br />
A. Sieg, Gastroenterologische Schwerpunktpraxis, Heildelberg,<br />
Germany<br />
Tubulovillous adenoma in rectosigmoid col<strong>on</strong><br />
Patient had complaints of c<strong>on</strong>stipati<strong>on</strong> alternating with diarrhea and no<br />
weight loss, no anemia/rectal bleeding. She had prior history of breast<br />
cancer (surgery, chemotherapy) and chr<strong>on</strong>ic GERD. CCE findings: Polyp in<br />
the rectosigmoid col<strong>on</strong> was detected.<br />
Post-CCE: Biopsies via col<strong>on</strong>oscopy were performed. Histological<br />
diagnosis: tubulovillous adenoma, moderate but focal high-grade dysplasia.<br />
Surgery: Resecti<strong>on</strong> (15 cm) of the rectosigmoid by laparoscopy. Follow-up<br />
col<strong>on</strong>oscopy showed absence of lesi<strong>on</strong> at > 1 year post-surgery. Patient is<br />
well and next follow-up is in 3 years.<br />
A. Van Gossum, Erasme Hospital, Brussels, Belgium<br />
*PillCam COLON has received a CE Mark, but is not cleared for marketing or available for commercial distributi<strong>on</strong> in the USA.
8 ICCE Workshop Report Vol. 1<br />
Workflow and Practical Guidelines<br />
Recipients of Awards Presented at ICCE<br />
The European Capsule Endoscopy Group (ECEG), established during United European<br />
Gastroenterology Week (UEGW) 2004 in Prague, initiated the ECEG Research Grant<br />
“to support innovative research in gastroenterology with substantial involvement in<br />
<strong>capsule</strong> <strong>endoscopy</strong>.” At ICCE Berlin, Chairman of the ECEG Research Grant Committee<br />
T. P<strong>on</strong>ch<strong>on</strong> (France) announced the recipients of the 2008 grants:<br />
• Principal Investigator I. Fernández-Urién (Spain) for a pilot, prospective 6-site<br />
multicenter study <strong>on</strong> the role of CE in patients with Stage III-IV melanoma.<br />
• Prinicipal Investigator H. Glerup (Denmark) and the research team of B. Larsen, R. Oestgaard, B. Deuleran for their study<br />
using CE to evaluate Crohn’s disease in ankylosing sp<strong>on</strong>dylitis.<br />
See www.CapsuleEndoscopy.org for <strong>on</strong>line applicati<strong>on</strong> informati<strong>on</strong> for ECEG Research Grants.<br />
Many thanks to those who c<strong>on</strong>tributed to this ICCE Workshop Report.<br />
Visit www.ICCE.info for important informati<strong>on</strong> <strong>on</strong> the c<strong>on</strong>ference and<br />
www.CapsuleEndoscopy.org for more informati<strong>on</strong> <strong>on</strong> <strong>capsule</strong> <strong>endoscopy</strong>.<br />
See you at the next ICCE.<br />
Ellen F. Bodner, Editor, ICCE Workshop Report<br />
As with any new modality, col<strong>on</strong> <strong>capsule</strong><br />
<strong>endoscopy</strong> involves a learning process—the<br />
PillCam COLON video <strong>capsule</strong> is unique<br />
in enabling direct visualizati<strong>on</strong> of col<strong>on</strong><br />
mucosa through clear fluid without using<br />
insufflati<strong>on</strong>.<br />
J. M. Herrerías (Spain) and M. E. Ricci<strong>on</strong>i<br />
(Italy) gave presentati<strong>on</strong>s that focused <strong>on</strong><br />
practical guidelines and how CCE can fit<br />
into the workflow of a GI practice. Ricci<strong>on</strong>i<br />
described the various RAPID features for<br />
effective reading of PillCam COLON videos<br />
as well as tips for using:<br />
• Schematic Col<strong>on</strong> Track, a tracing tool for<br />
localizati<strong>on</strong> allowing c<strong>on</strong>venient and quick<br />
identificati<strong>on</strong> of the col<strong>on</strong> secti<strong>on</strong> being<br />
viewed (right, transverse, or left col<strong>on</strong>)<br />
• Image Enhancement and Adjustment<br />
• Polyp Size Estimati<strong>on</strong><br />
At the c<strong>on</strong>clusi<strong>on</strong> of the <str<strong>on</strong>g>workshop</str<strong>on</strong>g>, Herrerías proposed detailed diagnostic algorithms for CCE for CRC preventi<strong>on</strong> and other<br />
indicati<strong>on</strong>s for col<strong>on</strong>ic examinati<strong>on</strong>. Such algorithms can stimulate discussi<strong>on</strong> and future studies about where CCE with PillCam<br />
COLON fits in the workflow with other diagnostic modalities.<br />
In his closing remarks at the <str<strong>on</strong>g>1st</str<strong>on</strong>g> Internati<strong>on</strong>al ICCE Workshop <strong>on</strong> Col<strong>on</strong> Capsule Endoscopy, co-chair G. Costamagna (Italy)<br />
c<strong>on</strong>cluded:<br />
“This is <strong>on</strong>ly the beginning—the best is yet to come.”<br />
To learn more about CCE, visit www.CapsuleEndoscopy.org or c<strong>on</strong>tact your Given Imaging representative for educati<strong>on</strong>al<br />
opportunities such as courses, presentati<strong>on</strong>s at <str<strong>on</strong>g>internati<strong>on</strong>al</str<strong>on</strong>g> c<strong>on</strong>gresses, professi<strong>on</strong>al societies, and local <strong>capsule</strong> clubs.<br />
This ICCE Workshop was sp<strong>on</strong>sored by<br />
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